Agriculture, Rural Development, and Related Agencies Appropriations for 1982: Hearings Before a Subcommitee of the Committee on Appropriations, House of Representatives, Ninety-sixth Congress, First Session, Parts 5-6U.S. Government Printing Office, 1981 - United States |
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Page 27
... request for a meet- ing , stating : While we continue to feel that a pre - NDA meeting would have been useful if it had been held at an earlier state in the preparation of the NDA , preparation of the NDA has now progressed to the point ...
... request for a meet- ing , stating : While we continue to feel that a pre - NDA meeting would have been useful if it had been held at an earlier state in the preparation of the NDA , preparation of the NDA has now progressed to the point ...
Page 28
... requests , has the FDA neve commented on any of the SSPE data sent in by Newport ? Dr. NOVITCH . It should be noted that as a ... request in a Wall Street Jour nal press release , September 18 , 1979. The Agency did rebut the sponsor's ...
... requests , has the FDA neve commented on any of the SSPE data sent in by Newport ? Dr. NOVITCH . It should be noted that as a ... request in a Wall Street Jour nal press release , September 18 , 1979. The Agency did rebut the sponsor's ...
Page 29
... REQUEST TO WITHHOLD CONTROVERSIAL DRUG - DENIAL OF ISOPRINOSINE TO NEW PATIENTS CALLED " IMMORAL " BY COMPANY IN CALIFORNIA NEWPORT BEACH , CALIF . - Newport Pharmaceuticals International Inc. said the Food and Drug Administration made ...
... REQUEST TO WITHHOLD CONTROVERSIAL DRUG - DENIAL OF ISOPRINOSINE TO NEW PATIENTS CALLED " IMMORAL " BY COMPANY IN CALIFORNIA NEWPORT BEACH , CALIF . - Newport Pharmaceuticals International Inc. said the Food and Drug Administration made ...
Page 35
... requested that Newport submit historical data to substantiate its claims . Newport was advised that FDA would schedule a meeting as soon as the data requested were reviewed and evaluated . The company later withdrew its request for a ...
... requested that Newport submit historical data to substantiate its claims . Newport was advised that FDA would schedule a meeting as soon as the data requested were reviewed and evaluated . The company later withdrew its request for a ...
Page 47
... request for 1982 for the control of chemical residues , and what are your thoughts on the fact that the FSQS request was approved by both the old Administration and the new Administra- tion , but yours was not ? Dr. NOVITCH . Our ...
... request for 1982 for the control of chemical residues , and what are your thoughts on the fact that the FSQS request was approved by both the old Administration and the new Administra- tion , but yours was not ? Dr. NOVITCH . Our ...
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Common terms and phrases
action activities additional aflatoxin agency agency's amended ampicillin analysis analyzed animal drugs appropriate approval approximately benzodiazepines blood budget Bureau carcinogen chemical cimetidine clinical Committee commodities compliance Conduct consumer contamination cosmetic costs determine digoxin dispensers distribution dose Drug Administration Drug Applications effects established Estimated evaluation facilities FDA's Federal Register feed Food and Drug Food Safety FSQS funds HOUSTON human implementation increase industry initial inspection investigations laboratory manufacturers meat and poultry medical devices ment methods methoxsalen million monitoring NOVITCH orphan drugs patient package inserts percent personnel pesticide petition pharmacists pharmacy phenytoin potential POULTRY PRODUCTS PPIs prescription drug problems procedures proposed radiation regulations regulatory reports request requirements response revised risk samples scientific September 12 Service SODIUM specific standards submitted testing thiazide tion toxic Toxicology USDA vaccines warfarin WHITTEN